FDA.reportPublic FDA data

MyoSleeve

Primary DI
07290020483065
Brand
MyoSleeve
Company
ELASTIMED LTD
Model
1.0
Catalog number
HL-XL-Rt-St
Device description
MyoSleeveHalf leg, X-Large, Right, Short
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232300000ElastiMed SACSElastimed , Ltd.2023-12-22JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290020483062PackageGS11In Commercial Distribution
27290020483069PackageGS12In Commercial Distribution
47290020483063PackageGS14In Commercial Distribution
07290020483065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729002048306217290020483062
2729002048306927290020483069
4729002048306347290020483063
07290020483065072900204830657290020483065

GMDN Terms#

Term, Definition table
TermDefinition
Wearable sequential venous compression systemA noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor with a compressing mechanism (e.g., pump, contracting straps) intended to be strapped to the calf, which provides a continuous peristaltic wave motion, and used for prescribed periods of treatment. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized/institutionalized patients.

Contacts#

Phone, Email table
PhoneEmail
+1(844) 679-9100support@elastimed.com

Regulatory Flags#

DUNS number
600461703
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290020483089SACS PRO1.0Pro-HL2026-05-06
07290020483010MyoSleeve1.0HL-S-Lt-St2026-01-01
07290020483027MyoSleeve1.0HL-M-Rt-St2026-01-01
07290020483034MyoSleeve1.0HL-M-Lt-St2026-01-01
07290020483041MyoSleeve1.0HL-L-Rt-St2026-01-01
07290020483058MyoSleeve1.0HL-L-Lt-St2026-01-01
07290020483072MyoSleeve1.0HL-XL-Lt-St2026-01-01
17290020483017MyoSleeve1.0HL-S-Lt-St2026-01-01
17290020483024MyoSleeve1.0HL-M-Rt-St2026-01-01
17290020483031MyoSleeve1.0HL-M-Lt-St2026-01-01
17290020483048MyoSleeve1.0HL-L-Rt-St2026-01-01
17290020483055MyoSleeve1.0HL-L-Lt-St2026-01-01
17290020483062MyoSleeve1.0HL-XL-Rt-St2026-01-01
17290020483079MyoSleeve1.0HL-XL-Lt-St2026-01-01
07290020483003MyoSleeve1.0HL-S-Rt-St2025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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